PMA supplement
P010031 S232: CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT
FDA PMA supplement · Panel Track · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P010031 |
|---|---|
| Supplement number | S232 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | NIK |
| Received date | Jan 24, 2011 |
| Decision date | Apr 4, 2012 |
| Docket number | 12M-0814 |
| Notice date | Jul 31, 2012 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: